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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 54 Results
productcode LWP PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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pacemaker devices BOSTONSCIENTIFIC P150012 S131 12/20/2022
pg essentio mri sr, pg essentio mri dr, pg propone... BOSTONSCIENTIFIC P150012 S138 12/20/2022
ingevity+ and ingevity mri BOSTONSCIENTIFIC P150012 S137 12/15/2022
essentio™ mri sr, essentio™ mri dr, essentio™ mri ... BOSTONSCIENTIFIC P150012 S136 12/14/2022
mri pacemakers BOSTONSCIENTIFIC P150012 S132 12/12/2022
accolade family of devices pacemakers, and cardiac... BOSTONSCIENTIFIC P150012 S134 12/12/2022
assurity mri, endurity mri Abbott Medical P140033 S076 12/07/2022
attain bipolar otw lead, attain otw lv lead, consu... MEDTRONIC Inc. P010015 S510 11/22/2022
consulta crt-p, percepta bipolar crt-p, percepta q... MEDTRONIC Inc. P010015 S511 11/22/2022
capsurefix mri lead Medtronic, Inc P090013 S325 11/22/2022